Karunakar Sukuru (Karu), R.Ph., Ph.D.

Segment Vice President, Global Product Development & Innovation

Catalent

The CPHI Milan conference sessions, taking place October 6-8, 2026, represent a unique opportunity to gain insights from industry leaders shaping the future of the pharmaceutical industry and supply chain.

In an industry navigating unprecedented complexity, from supply chain disruptions and geopolitical uncertainties to the rising demand for patient-centric therapies, pharmaceutical development requires both scientific innovation and strategic foresight. In this exclusive interview, Karunakar Sukuru, RPh, PhD, Segment Vice President, Global Product Development & Innovation, sponsors of this year’s Supply & Formulation Excellence Track, brings a unique perspective on how formulation science, supply chain resilience, and collaborative partnerships are reshaping the future of oral drug delivery.

1. In an era of supply chain fragmentation and geopolitical tensions, how are companies like Catalent restructuring sourcing strategies to balance resilience with cost efficiency?

"Today, supply chain resilience has become a strategic differentiator because continuity of supply is ultimately a patient issue as much as a business one. Increasingly, resilience is being built into programs from the earliest stages through formulation selection, raw material sourcing, manufacturing process design, and tech transfer planning. These early decisions have a significant impact on long-term supply flexibility, scalability, and commercial success. At Catalent, we work with customers to identify potential vulnerabilities before they become constraints. That may involve qualifying multiple sources for critical materials, selecting formulation strategies that provide greater flexibility, or designing manufacturing processes that can be efficiently transferred across our global network. The goal is to reduce risk while creating optionality without compromising quality, regulatory compliance, or speed-to-market. From a sourcing perspective, resilience today also requires a diversified supplier ecosystem, strategic dual sourcing of critical materials, stronger supplier partnerships, and greater visibility into tier-two and tier-three supply networks. Catalent evaluates sourcing decisions through both a risk and a value lens, balancing continuity of supply, quality, regulatory compliance, and total landed cost. By integrating procurement, development, and manufacturing strategies from the outset, we help customers build supply chains that are not only more resilient, but also more agile and better positioned to navigate an increasingly dynamic global environment."

2. Patient-centric drug development has become a major industry focus. How are formulation scientists balancing technical performance with patient experience when designing the next generation of medicines?

"Beyond proving safety and efficacy, innovators must now consider how dosage form, convenience, and ease-of-administration influence long-term patient adherence and, ultimately, real-world outcomes. That means formulators must think beyond pharmacokinetics and consider dose burden, swallowability, convenience, portability, and the patient experience much earlier in development. Increasingly, sponsors are incorporating patient use studies into clinical development to understand how patients interact with a medicine to generate insights that can inform dosage form selection, packaging, instructions for use, and overall product design before commercialisation. Whether through innovative oral dosage forms, flexible dosing formats, or improved delivery technologies, designing around the patient often translates into better adherence, improved outcomes, and stronger commercial performance."

3. As oral pipelines become more complex, how do you see the role of CDMOs evolving from manufacturing partners to scientific innovation partners?

"As drug candidates become increasingly complex, the relationship between innovators and CDMOs is becoming far more collaborative. Today, customers need more than manufacturing capacity, they need scientific expertise that helps determine whether a molecule is suitable for oral delivery and which formulation and development strategy will provide the highest probability of success. Selecting the right enabling technology and dosage form can have a profound impact on bioavailability, patient experience, and ultimately commercial performance. For example, lipid-based formulations and advanced softgel technologies can enhance the oral delivery of poorly soluble compounds and reduce pill burden, while patient-centric dosage forms such as Zydis® ODT can improve ease of administration for pediatric, geriatric, and dysphagic patients. At Catalent, we view ourselves as scientific innovation partners from the earliest stages of development. Our Scientific Advisory and product development teams work alongside our customers to evaluate technical feasibility, de-risk development, incorporate patient-centric considerations, and design formulations with scalable commercial manufacturing in mind from the start. Manufacturing remains a critical part of the equation, but our greatest value increasingly comes from helping customers make better scientific and strategic decisions earlier in the development journey."

4. What emerging technologies is Catalent prioritising to address the evolving complexity of pharmaceutical formulations?

"Catalent continues to invest in technologies that enable the next generation of oral therapies. We're seeing strong momentum behind lipid-based drug delivery systems, advanced softgel technologies, lyophilized dosage forms such as Zydis® ODT, spray-dried dispersions (ASD), modified-release platforms, particle engineering, and bioavailability enhancement technologies. These approaches are becoming increasingly important for enabling oral delivery of poorly soluble compounds, PROTACs, peptides, and other challenging molecules. Equally important is the integration of advanced modelling and material characterisation that allow formulators to make better-informed decisions earlier in development. Together, these technologies are helping expand what's possible, from transforming injectables into patient-friendly oral therapies to broadening treatment options and ultimately delivering better patient outcomes."

5. How do industry events like CPHI Milan facilitate critical conversations around supply chain security, formulation innovation, and regulatory compliance, and how has Catalent used these events to drive tangible industry progress?

"Many of today's biggest pharmaceutical challenges, from ensuring reliable supply to enabling oral delivery of complex molecules require collaboration across innovators, CDMOs, technology providers, and regulators. For Catalent, CPHI Milan provides an important platform to share scientific insights, showcase emerging formulation technologies and engage in discussions about the future of drug development. Equally important, it strengthens supply chain resilience through direct engagement with suppliers, enabling us to benchmark sourcing strategies, identify alternative supply options, understand evolving regulatory requirements, and gain insight into the market forces shaping pharmaceutical supply chains. These interactions often become the foundation for long-term partnerships that accelerate innovation, strengthen supply continuity, and improve the reliable delivery of increasingly complex therapies to patients. By bringing together scientific, operational, and supply chain expertise in one forum, CPHI Milan helps Catalent and its partners develop more resilient, patient-focused solutions that move promising oral therapies from development to commercialisation with greater confidence."